TY - JOUR
T1 - Thromboembolic event rate in paroxysmal and persistent atrial fibrillation
T2 - Data from the GISSI-AF trial
AU - Disertori, Marcello
AU - Franzosi, Maria G.
AU - Barlera, Simona
AU - Cosmi, Franco
AU - Quintarelli, Silvia
AU - Favero, Chiara
AU - Cappellini, Glauco
AU - Fabbri, Gianna
AU - Maggioni, Aldo P.
AU - Staszewsky, Lidia
AU - Moroni, Luigi A.
AU - Latini, Roberto
PY - 2013/4/15
Y1 - 2013/4/15
N2 - Background: Few data on the thromboembolic (TE) risk of paroxysmal and persistent atrial fibrillation (AF) are available. This study aimed to assess the incidence of TE events in paroxysmal and persistent AF.Methods: We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter, prospective, randomized, double-blind, placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences - where the choice of antithrombotic treatment was left to the judgment of the referring physician. TE and major outcome events were centrally validated. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions.Results: Eighty-five percent of patients had a history of hypertension, and the 7.7% had heart failure, left ventricular dysfunction, or both. The mean CHADS2 score was 1.41±0.84. TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up (0.97% and 0.81%, respectively). The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE, major bleeding events or mortality in paroxysmal and persistent AF patients. TE events were more common among women than men (p=0.02). The follow-up examination showed under- or overtreatment with warfarin in many patients, according to guideline suggestions. Warfarin was more frequently prescribed to patients with persistent AF (p2 score (HR 2.93; CI 95%; 0.8-10.9; p=0.11).Conclusions: TE and major bleeding events showed a very low incidence in the GISSI-AF trial population, despite under- or overtreatment with warfarin in many patients. TE events had a similar rate in paroxysmal and persistent AF.Trial registration: Trial registration number: NCT00376272.
AB - Background: Few data on the thromboembolic (TE) risk of paroxysmal and persistent atrial fibrillation (AF) are available. This study aimed to assess the incidence of TE events in paroxysmal and persistent AF.Methods: We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter, prospective, randomized, double-blind, placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences - where the choice of antithrombotic treatment was left to the judgment of the referring physician. TE and major outcome events were centrally validated. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions.Results: Eighty-five percent of patients had a history of hypertension, and the 7.7% had heart failure, left ventricular dysfunction, or both. The mean CHADS2 score was 1.41±0.84. TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up (0.97% and 0.81%, respectively). The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE, major bleeding events or mortality in paroxysmal and persistent AF patients. TE events were more common among women than men (p=0.02). The follow-up examination showed under- or overtreatment with warfarin in many patients, according to guideline suggestions. Warfarin was more frequently prescribed to patients with persistent AF (p2 score (HR 2.93; CI 95%; 0.8-10.9; p=0.11).Conclusions: TE and major bleeding events showed a very low incidence in the GISSI-AF trial population, despite under- or overtreatment with warfarin in many patients. TE events had a similar rate in paroxysmal and persistent AF.Trial registration: Trial registration number: NCT00376272.
KW - Atrial fibrillation recurrences
KW - Paroxysmal atrial fibrillation
KW - Persistent atrial fibrillation
KW - Thromboembolic risk
KW - Warfarin
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U2 - 10.1186/1471-2261-13-28
DO - 10.1186/1471-2261-13-28
M3 - Article
C2 - 23586654
AN - SCOPUS:84876104804
VL - 13
JO - BMC Cardiovascular Disorders
JF - BMC Cardiovascular Disorders
SN - 1471-2261
M1 - 28
ER -